Filling Setup Operator - 2nd Shift

About the role

At Guerbet, we build lasting relationships so that we enable people to live better. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate. Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice. For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, X, Instagram, and YouTube. The Filling Setup Operator is responsible for preparing the manufacturing equipment to produce pharmaceutical products in an aseptic environment in accordance with company standard operating procedures. This position will monitor the equipment during each batch operation to ensure that quality and safety are maintained throughout the manufacturing process. The Filling Setup Operator will also be responsible for completing all necessary documentation related to the manufacturing process while adhering to cGMP and GDP guidelines. The Filling Setup Operator operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

Responsibilities

• Set up and configure filling equipment for specific products, ensuring proper calibration and compliance with Standard Operating Procedures (SOPs) and GMP standards.
• Disassemble the filling equipment as necessary.
• Troubleshoot minor mechanical issues and escalate complex problems to maintenance as needed to ensure smooth operations.
• Operate autoclave equipment for sterilization and filling processes.
• Monitor and adjust filling equipment to ensure efficient and accurate production.
• Perform environmental monitoring and in-process checks to ensure compliance with regulatory requirements.
• Perform cleaning and sanitization of clean room areas using approved disinfectants using aseptic techniques to maintain sterile conditions.
• Maintain strict adherence to aseptic techniques during all operations, including gowning, material transfer, and interventions in clean rooms.
• Understand and apply principles of sterility assurance, including proper handling of sterile components and monitoring of aseptic conditions.
• Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic environment.
• Accurately complete all documentation including but not limited to batch records, logbooks, and deviation reports in compliance with cGMP and data integrity requirements.
• Ensure high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Promptly report and assist in investigation of any contamination events or deviations.
• Comply with departmental objectives including improving safety and performance, reducing deviations, and training compliance.
• Perform other duties as assigned by management.
• Prevent excess waste of product and/or components by operating the equipment in an efficient manner.
• Collaborate with Engineering, Validation, and other departments in initiating and implementing programs such as Continuous Improvement (Lean and 5S) and Total Productive Maintenance.
• Cross-training to perform tasks and roles outside of the primary responsibilities.

Requirements

• High School Diploma, GED, or equivalent required.
• 2-5 years’ experience as a Production Set-Up Operator in a pharmaceutical manufacturing environment preferred.
• Knowledge of basic computer skills and Microsoft Office.
• Skilled in the proper handling and use of basic hand tools for routine adjustments and minor maintenance.
• Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques.
• Ability to stand for extended amounts of time.
• Must be able to continuously lift a minimum of 50 Ibs.
• Ability to operate an electric pallet